De Novo · Granted
GrantedClaria System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Claria Medical, Inc. · SIM Gynecologic Power Morcellator And Containment System
Granted on Jul 2, 2026 as a new device type through De Novo after a 329-day review.
- Decided
- Jul 2, 2026
- Review
- 329 days
- Class
- Class II
- Product code
- SIM
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SIM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SIM devicesSIM Gynecologic Power Morcellator And Containment System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SIM
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SIM
Too few SIM 510(k)s in any year since 2007 to give a median.
Recalls per year · SIM
No recall names SIM since 2007.
Adverse event reports per year · SIM
No MAUDE report names SIM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Claria System is indicated for contained cutting, coring, and extraction of tissue during laparoscopic hysterectomy. The Claria Container is introduced transvaginally to isolate and contain tissue considered benign during powered bulk tissue reduction with the Claria Bulk Tissue Reducer. When used in women with fibroids, the Claria System is for women who are pre-menopausal and under age 50.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250034 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250034: Claria System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250034
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026